Duns Number:023904428
Device Description: Extension Feeding Set SINGLE ENFit® PORT Straight CONNECTOR WITH CLAMP 12 in
Catalog Number
-
Brand Name
Mckesson
Version/Model Number
194-0123-12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PIF
Product Code Name
Gastrointestinal Tubes With Enteral Specific Connectors
Public Device Record Key
3ac4fc1b-b437-4f5e-b8c9-db9f6e38da8a
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 23, 2020
Package DI Number
20612479250738
Quantity per Package
5
Contains DI Package
10612479250724
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |